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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03744468




Registration number
NCT03744468
Ethics application status
Date submitted
17/10/2018
Date registered
16/11/2018
Date last updated
15/05/2020

Titles & IDs
Public title
Study of BGB-A425 in Combination With Tislelizumab in Advanced Solid Tumors
Scientific title
Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
BGB-900-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-A425
Treatment: Drugs - tislelizumab

Experimental: Phase 1 Dose Escalation - Dose escalation of BGB-A425 in combination with tislelizumab in participants with advanced solid tumors

Experimental: Phase 2 Dose Expansion - Further explore the safety and clinical activity of BGB-A425 in combination with tislelizumab in participants with select advanced solid tumors


Treatment: Drugs: BGB-A425
Humanized IgG1-variant monoclonal antibody against TIM-3

Treatment: Drugs: tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1 Dose Escalation - Safety and tolerability of BGB-A425 in combination with tislelizumab using Common Terminology Criteria for Adverse Events (CTCAE v.5.0) in participants with advanced solid tumors.
Timepoint [1] 0 0
Approximately 2 years
Primary outcome [2] 0 0
Phase 2 Dose Expansion - Recommended Phase 2 dose (RP2D) of BGB-A425 in combination with tislelizumab [ Phase 1 Dose Escalation - Approximately 1.5 years ]; 3. Anti-tumor activity of BGB-A425 in combination with tislelizumab in participants with select advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Timepoint [2] 0 0
Approximately 2 years
Primary outcome [3] 0 0
Anti-tumor activity of BGB-A425 in combination with tislelizumab in participants with select advanced solid tumors, in terms of objective response rate (ORR) - Assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Duration of response (DOR) - Duration of response (DOR) will be determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Timepoint [1] 0 0
Phase 1 or 2 Expansion - Approximately 2-3 years each
Secondary outcome [2] 0 0
Disease control rate (DCR) - Disease control rate (DCR) will be determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Timepoint [2] 0 0
Phase 1 or 2 Expansion - Approximately 2-3 years each
Secondary outcome [3] 0 0
Progression free survival - Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.
Timepoint [3] 0 0
Phase 2 Expansion - Approximately 3 years
Secondary outcome [4] 0 0
PK Parameter: Area Under the Curve (AUC), 0 to 21 days
Timepoint [4] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [5] 0 0
Pharmacokinetic (PK) Parameter: Minimum Concentration (Cmin)
Timepoint [5] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [6] 0 0
PK Parameter: Maximum Concentration (Cmax)
Timepoint [6] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [7] 0 0
PK Parameter: Clearance (CL)
Timepoint [7] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [8] 0 0
PK Parameter: Volume of Distribution (Vz)
Timepoint [8] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [9] 0 0
PK Parameter: terminal half-life (t1/2)
Timepoint [9] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [10] 0 0
Immunogenicity as assessed by the presence of anti-drug antibodies
Timepoint [10] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each

Eligibility
Key inclusion criteria
Key

1. Phase 1: Patients with histologically or cytologically confirmed advanced, metastatic,
unresectable solid tumors who have previously received standard systemic therapy or
for which treatment is not available, not tolerated or refused.

2. Has Eastern Cooperative Oncology Group (ECOG) Performance Status =1.

3. Has adequate organ function.

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active, untreated, or uncontrolled brain metastasis or leptomeningeal disease.

2. Active autoimmune diseases or history of autoimmune diseases that may relapse.

3. With infections (including tuberculosis infection, etc) requiring systemic
antibacterial, antifungal, or antiviral therapy = 14 days prior to the first dose of
study drug(s), or a requirement for chronic prophylactic treatment with antibiotics.

5. Concurrent participation in another therapeutic clinical trial. 6. Received prior
therapies targeting TIM-3.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
BGB-A425 is a humanized, immunoglobulin gamma-1 (IgG1)-variant monoclonal antibody against
TIM-3. Tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody
against PD-1. This study tests the safety and anti-tumor effect of BGB-A425 in combination
with tislelizumab in participants with advanced solid tumors.
Trial website
https://clinicaltrials.gov/show/NCT03744468
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jayesh Desai, MD
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
1 (877) 828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03744468